Data / Medical devices / France / Firalis S.A.
Firalis S.A.: FDA-registered device maker in Huningue Haut-Rhin, France, 1 510(k) clearance
Firalis S.A. is registered with the FDA (registration 3009523773) in Huningue Haut-Rhin, France. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009523773
- Address
- 35, rue du Fort, Huningue Haut-Rhin, France, 68330
- Owner or operator
- FIRALIS S.A. (10093823)
- Roles
- Manufacturer
- First device listed
- July 16, 2025
- Registered through
- 2026
- Brand names listed
- APO-Easy® genotyping kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurologic Disease Risk Assessment Molecular Test | SFC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2025 | DEN240032 | APO-Easy Genotyping kit | SFC | Unknown | Firalis SA | accessdata.fda.gov |
Updated June 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.